MAUDE Adverse Event Report: SPECTRUM MEDICAL LIMITED QUANTUM DIAGNOSTICS MODULE; GAS DIAGNOSTC MODULE

Model Number	QDM1
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reported issue is human error and not a device malfunction.During a pm the gas tubings need to be disconnected/removed from the qdm to access the device to replace the internal o2 cell.After o2 cell replacement a gas calibration is performed.Gas tubing from the blender to the qdm and qdm to exhaust module is required.It is suspected that the tubing wasn't pushed on completely, came off post gas calibration or was forgotten to be reconnected.
Event or Problem Description
User reported that they noticed dark arterial blood and low svo2 on initial of bypass whilst manual gas blender 02 sweep was set at 2l and fio2 set at 100%.The patient was weaned off bypass to allow for reoxygenation via the ventilator and to have time to trouble shoot the gas issue.On inspection, the user reported that they noticed that the gas supply from manual gas blender to qdm was not complete on the qdm.The gas circuit was reconnected, and bypass was re-initiated without further issues.

• Brand Name: QUANTUM DIAGNOSTICS MODULE
• Common Device Name: GAS DIAGNOSTC MODULE
• Manufacturer (Section D): SPECTRUM MEDICAL LIMITED; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL2 9 QL; UK GL2 9QL
• Manufacturer (Section G): SPECTRUM MEDICAL LTD.; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL2 9 QL; UK GL2 9QL
• Manufacturer Contact: angus fletcher ; harrier4, meteor business park; cheltenham east road; gloucester, gloucestershire GL29Q-L ; UK GL29QL
• MDR Report Key: 19679460
• Report Number: 3006073153-2024-00007
• Device Sequence Number: 3166183
• Product Code: DTX
• UDI-Device Identifier: 05060434420701
• UDI-Public: 05060434420701
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K181942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: QDM1
• Device Catalogue Number: 51-000023-00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown